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NCT00001117

A Study to Evaluate the Effects of Anti-HIV Drugs in HIV-Positive Patients Who Also Have Hepatitis C Infection

Last Updated: 2008-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Brief Summary

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This study evaluates patients infected with both HIV and Hepatitis C virus (HCV) who are receiving anti-HIV drugs. The purpose of this study is to learn more about HCV infection in patients whose HIV blood level decreases to less than 500 copies/ml.

Detailed Description

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Sixty naive patients with HIV and confirmed hepatitis C who are co-enrolled in another AACTG antiretroviral study that involves the testing of HAART (Highly Active Antiretroviral Therapy) are entered on this prospective study. Patients who are defined as naive have never received specific, active antiretroviral agents that sustain viral suppression below the limit of detection (500 copies/ml) or have received those agents for only a very limited time. HAART is defined as therapy which is likely to result in HIV-1 RNA plasma levels less than 500 copies/ml for at least 16 weeks. Plasma is collected and evaluated during the study for additional quantitative measurements: Hepatitis C virus (HCV) by HCV RNA PCR and HIV-1 RNA levels. All evaluations for HIV-1 RNA are obtained from the co-enrolled study at the following time points: Pre-entry, entry, at least 2 measurements before Week 16, Week 16, and at least 1 measurement after Week 16.

Conditions

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HIV Infections Hepatitis C

Keywords

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HIV-1 Drug Therapy, Combination Hepatitis C RNA, Viral Anti-HIV Agents

Eligibility Criteria

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Inclusion Criteria

Patients may be eligible for this study if they:

* Are HIV-positive and have Hepatitis C.
* Have an HIV blood level of at least 2,500 copies/ml 30 days before study entry.
* Are co-enrolled in an active adult AIDS clinical trial using anti-HIV treatment.
* Are at least 13 years of age (parent or guardian consent required if under 18).

Exclusion Criteria

Patients will not be eligible for this study if they:

* Have liver disease.
* Have cancer requiring chemotherapy.
* Have Hepatitis B.
* Abuse alcohol and/or drugs.
* Have received certain antiretroviral (anti-HIV) drugs in the past.

Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Principal Investigators

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Raymond Chung

Role: STUDY_CHAIR

Cecilia Shikuma

Role: STUDY_CHAIR

Locations

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Univ of Southern California / LA County USC Med Ctr

Los Angeles, California, United States

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Willow Clinic

Menlo Park, California, United States

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Univ of California / San Diego Treatment Ctr

San Diego, California, United States

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San Francisco Gen Hosp

San Francisco, California, United States

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Marin County Specialty Clinic

San Rafael, California, United States

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San Mateo AIDS Program / Stanford Univ

Stanford, California, United States

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Stanford Univ Med Ctr

Stanford, California, United States

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Harbor UCLA Med Ctr

Torrance, California, United States

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Univ of Colorado Health Sciences Ctr

Denver, Colorado, United States

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Howard Univ

Washington D.C., District of Columbia, United States

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Univ of Miami School of Medicine

Miami, Florida, United States

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Emory Univ

Atlanta, Georgia, United States

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Queens Med Ctr

Honolulu, Hawaii, United States

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Univ of Hawaii

Honolulu, Hawaii, United States

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Northwestern Univ Med School

Chicago, Illinois, United States

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Cook County Hosp

Chicago, Illinois, United States

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Rush Presbyterian - Saint Luke's Med Ctr

Chicago, Illinois, United States

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Louis A Weiss Memorial Hosp

Chicago, Illinois, United States

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Indiana Univ Hosp

Indianapolis, Indiana, United States

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Division of Inf Diseases/ Indiana Univ Hosp

Indianapolis, Indiana, United States

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Charity Hosp / Tulane Univ Med School

New Orleans, Louisiana, United States

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Tulane Univ School of Medicine

New Orleans, Louisiana, United States

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Johns Hopkins Hosp

Baltimore, Maryland, United States

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Harvard (Massachusetts Gen Hosp)

Boston, Massachusetts, United States

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Boston Med Ctr

Boston, Massachusetts, United States

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Univ of Minnesota

Minneapolis, Minnesota, United States

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St Louis Regional Hosp / St Louis Regional Med Ctr

St Louis, Missouri, United States

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